Abstract
Author(s): Madhuri A. Hinge*, Rajvi J. Mahida ,Piyush S. Sojitra
An RP-HPLC method has been developed and validated for the simultaneous determination of Trimetazidine Hydrochloride (TMZ) and Metoprolol Succinate (METO) in Tablets. In HPLC method, Enable C18 (250 x 4.6 mm,5 m ) column was used as stationary phase and Water: Methanol: Acetonitrile in the ratio 45:45:10, (v/v/v) (pH adjusted to 3.0 with ortho-phosphoric acid) as mobile phase was used. The flow rate was 1ml/min and both drugs were quantified at 274.0 nm. The retention time for TMZ and METO was found to be 2.61 ± 0.175 min and 4.12 ± 0.129 respectively.The method was validated according to ICH guidelines for various parameters like accuracy, precision, specificity, linearity, robustness, LOD and LOQ. The linearity of the proposed method was investigated in the range of 20-120 g/mL (r2=0.9977) for TMZ and 27 -162g/mL (r2= 0.9970) for METO. The limits of detection (LOD) were 1.205 μg/mL and 1.53 μg/mL for TMZ and METO, and the limits of quantitation (LOQ) were 3.652 μg/mL and 4.64 μg/mL, respectively. The obtained results proved that the method can be employed for the routine analysis of Trimetazidine Hydrochloride and Metoprolol Succinate in bulks as well as in the commercial formulations.
